PsyBio Therapeutics Initiates Process Development of Proprietary Biosynthetic Norbaeocystin

March 23, 2021
News

OXFORD, Ohio and COCONUT CREEK, Fla., March 23, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) ("PsyBio"), a leader in the field of psychedelic research and drug development, has initiated process development of its proprietary biosynthetic formulation of norbaeocystin in collaboration with the Advanced Biofuels and Bioproducts Process Development Unit, a scale-up facility managed by Lawrence Berkeley National Laboratory, a U.S. Department of Energy national laboratory. Norbaeocystin is an analogue of psilocybin and is not a controlled substance. The Company has commenced  Phase I of this process, including analytical chemistry technical transfer to establish detection methods for fermentation products and key feedstocks and metabolites.

"We are pleased to have moved our second product candidate intended to be utilized in conjunction with psilocybin from the laboratories of Dr. J. Andrew Jones at Miami University to a governermental research facility to begin preprarations to scale production of our proprietary biosynthetic norbaeocystin in anticipation for use in clinical trials," said Evan Levine, Chief Executive Officer of PsyBio. "This is a continuation of our endeavors to develop more nature inspired psychedelic therapeutics with improved characteristics and properties versus monotherapy psilocybin which is currently being studied broadly for potential activity against depression, anxiety, PTSD and substance abuse."

In collaboration with Miami University, Oxford Ohio, PsyBio is developing a portfolio of tryptamine derived therapeutic candidates inspired by plants and fungi with psychedelic properties that are intended to be studied in clinical trials to determine efficacy to improve patient outcomes for a variety of mental health and other disorders. Utilizing an efficient patent pending bacterial synthesis process, the Company is endeavoring to deliver a next generation of targeted psychoactive medications. It is expected that PsyBio's method enabling the rapid generation of a highly stable compound will be cheaper, faster and greener than any other published production method.

"In recent years,  psilocybin has been broadly accepted as a therapeutic candidate for a variety of health challenges, however, naturally occuring intermediates in the pathway have not shared similar research attention despite sharing many structural similarities to  psilocybin", stated J. Andrew Jones, Ph.D., Chairman of the Company's Scientific Advisory Board. "Our research is based on studying these other metabolites from the biosynthetic pathway to potentially develop superior therapeutics with improved medicinal properties. Through our research collaboration with Dr. Matthew McMurray in the psychology department at Miami University and direct access to an in house vivarium, we have been developing and filing intellectual property on tryptamine combinations that have not previously been studied, yet have demonstrated early indications of unique properties that our team is optimizing for intended clinical use."

About PsyBio Therapeutics Corp.

PsyBio is a biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health and other disorders. The team has experience in drug discovery based on synthetic biology as well as clinical and regulatory experience moving drugs through human studies and regulatory protocols. Research and development are currently ongoing for naturally occurring tryptamines found in different varieties of magic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new molecular structures that do not occur in nature which may have unique therapeutics properties.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including assumptions regarding: PsyBio's ability to protect its intellectual property within the next year and its ability to file new patent applications within that timeframe; PsyBio's ability to be successful in discovering new valuable target molecules; PsyBio's ability to obtain Investigation New Drug Applications and obtain all necessary approvals for clinical trials; PsyBio's ability to develop more nature inspired psychedelic therapeutics with improved characteristics; the safety and efficacy of PsyBio's technology; that drug development involves long lead times, is very expensive and involves many variables of uncertainty; and that PsyBio's technology will be cheaper, faster and greener than other published methods. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio's business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio's proposed products. The U.S. Food and Drug Administration (the "FDA") or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products have not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio's performance and operations.

The TSX Venture Exchange (the "TSXV") has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

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